# US 10,309,877 B2 · Method for analyzing atypical cells in urine, urine analyzer, and method for analyzing atypical cells in body fluid > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,309,877 B2 - Document ID: US10309877B2 - Status: Granted - Kind: B2 - Application number: 14/831,244 - Filed: 2015-08-20 - Published: 2016-02-25 - Granted: 2019-06-04 - Earliest claimed: 2014-08-25 - Assignees: Sysmex Corporation - Applicants: Sysmex Corporation - Inventors: Shota Tateyama; Masanori Kawano; Masatsugu Ozasa - Web page: https://patentgrep.com/patent/US10309877B2 ## CPC - G01N 1/31: Apparatus therefor - G01N 15/1459: {the analysis being performed on a sample stream} - G01N 33/493: urine - G01N 33/5005: {involving human or animal cells (immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025)} - G01N 33/57525: of the liver or pancreas - G01N 33/57585: {involving compounds identifiable in body fluids} - G01N 35/00: Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor - G01N 2015/1006: {for cytology} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Disclosed is a method for analyzing atypical cells in urine including: mixing urine, a diluent containing a surfactant, and a nucleic acid staining reagent to prepare a measurement specimen; irradiating the measurement specimen with light to detect scattered light and fluorescence light emitted from cells whose nucleic acids are stained; and detecting atypical cells contained in the measurement specimen distinguishably from white blood cells depending on a first characteristic parameter based on the scattered light and a second characteristic parameter based on the fluorescence light. ## Claims ### Claim 1 A method for analyzing atypical cells in urine, comprising: (a) mixing urine, a diluent containing a surfactant, and a nucleic acid staining reagent to prepare a measurement specimen; (b) irradiating the measurement specimen with light to detect scattered light and to detect fluorescence light, with first sensitivity and second sensitivity higher than the first sensitivity, emitted from cells whose nucleic acids are stained; and (c) detecting atypical cells contained in the measurement specimen distinguishably from white blood cells based on the detected scattered light and the fluorescence light detected with the first sensitivity, and detecting bacteria contained in the measurement specimen based on the detected scattered light and the fluorescence light detected with the second sensitivity. ### Claim 2 (depends on 1) The method according to claim 1, wherein in the step (c), the detected atypical cells are counted, and the method further comprises a step of outputting information indicating a presence of the atypical cells when a number of the atypical cells is larger than a predetermined number. ### Claim 3 (depends on 1) The method according to claim 1, wherein in the step (c), the detected white blood cells and the atypical cells are counted, and the method further comprises a step of displaying information based on a number of the atypical cells with a counting result of the white blood cells. ### Claim 4 (depends on 1) The method according to claim 1, wherein in the step (c), the atypical cells contained in the measurement specimen are detected distinguishably from the white blood cells and epithelial cells based on the detected scattered light and the fluorescence light detected by the first sensitivity. ### Claim 5 (depends on 1) The method according to claim 1, wherein in the step (c), the atypical cells contained in the measurement specimen are detected distinguishably from bacteria or fungi based on the detected scattered light and the fluorescence light detected by the first sensitivity. ### Claim 6 (depends on 1) The method according to claim 1, wherein the atypical cells contained in the measurement specimen are distinguishably detected from the white blood cells based on a first characteristic parameter of the scattered light, the first parameter reflecting a cell size, and a second characteristic parameter of the fluorescence light, the second parameter reflecting an amount of nucleic acids in cells. ### Claim 7 (depends on 6) The method according to claim 6, wherein in the step (c), at least a part of nucleated cell population contained in the measurement specimen is classified, based on the first characteristic parameter and the second characteristic parameter, into a first cell population having the first and the second characteristic parameters in a predetermined range, a second cell population having the first characteristic parameter higher than the first characteristic parameter of the first cell population, a third cell population having the first characteristic parameter higher than the first characteristic parameter of the first cell population and the second characteristic parameter higher than the second characteristic parameter of the second population, and the first to third cell populations are detected as white blood cells, epithelial cells, and atypical cells, respectively. ### Claim 8 (depends on 1) The method according to claim 1, further comprising a step of dividing the urine into at least a first aliquot and a second aliquot, wherein in the step (a), the first aliquot, the diluent, and the nucleic acid staining reagent are mixed to prepare a first measurement specimen as the measurement specimen, the second aliquot, a second diluent different from the diluent, and a reagent different from the nucleic acid staining reagent are mixed to prepare a second measurement specimen, in the step (c), white blood cells and atypical cells contained in the first measurement specimen are detected, and the method further comprises a step of detecting red blood cells contained in the second measurement specimen. ### Claim 9 (depends on 1) The method according to claim 1, wherein in the step (c), the atypical cells contained in the measurement specimen are detected distinguishably from the white blood cells and white blood cell clumps based on a third characteristic parameter based on the scattered light or the fluorescence light, in addition to the first characteristic parameter and the second characteristic parameter. ### Claim 10 (depends on 9) The method according to claim 9, wherein in the step (c), the white blood cell clumps contained in the measurement specimen are detected distinguishably from the atypical cells and counted, and the method further comprises a step of outputting information based on the number of the white blood cell clumps. ### Claim 11 (depends on 9) The method according to claim 9, wherein the third characteristic parameter is a parameter indicating whether a pulse included in a signal that indicates a temporal change of an intensity of the scattered light or the fluorescence light is monophasic or multiphasic. ### Claim 12 (depends on 11) The method according to claim 11, wherein the third characteristic parameter is a ratio between a difference integrated value and a peak value of the pulse. ### Claim 13 (depends on 6) The method according to claim 6, wherein the first characteristic parameter is a peak value of a pulse included in the detected scattered light signal that indicates a temporal change of an intensity of the scattered light, a width of the pulse, or an area of the pulse. ### Claim 14 (depends on 6) The method according to claim 6, wherein the second characteristic parameter is a width of a pulse included in the detected fluorescence signal that indicates a temporal change of an intensity of the fluorescence light, or an area of the pulse.